Brain [18F]-FES PET/CT in the Diagnosis, Treatment Planning and Response Assessment of Brain Metastases in Patients With Estrogen-Receptor Positive Breast Cancer
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- SUV Ratio
研究概览
简要总结
The goal of this interventional study is to optimize the protocol of FES PET/CT in Estrogen Receptor positive Breast cancer patients with Brain metastases. Patients will undergo MRI of the brain and FDG PET/CT brain as part of standard of care for radiation treatment planning. An additional 18F-FES PET/CT brain scan will be completed before this standard of care radiation treatment. Patients will be followed prospectively with clinical and MRI assessments per standard-of-care for a total of 12 months.
Study Population: Patients with ER-positive breast cancer with biopsy proven or suspected new or recurrent brain metastases (based on standard of care MRI) planned for radiation treatment of brain lesions.
详细描述
Objectives
- Evaluate the kinetics of dynamic brain FES PET/CT and optimize acquisition protocol.
- Evaluate utility of FES PET/CT as an adjunct modality in radiotherapy planning.
- (Exploratory aim) Determine correlation between FES PET metrics and survival metrics.
Overall Design All subjects will undergo a MRI brain and FDG PET/CT brain scan as part of clinical standard- of-care for radiation treatment planning. An additional 18F-FES PET/CT brain scan will be performed as part of this study prior to standard of care radiation treatment. 18F-FES is clinically approved for the study population, however has to date not been widely used in the clinical context of differentiating brain metastases from radiation sequela. The 18F-FES PET/CT scan will be completed within approximately 2 days to 4 weeks of the 18F-FDG PET/CT, and 2 days to 4 weeks of the MRI brain, respectively. While MRI and PET can be performed on the same day if needed, the 18F-FDG PET/CT and 18F-FES PET/CT have to be separated by at least 1 day, to allow for 10 half-lives of 18F (10 times 108 minutes = 18 hours) to pass in order to avoid signal overlap on the second PET/CT scan. Subjects will be followed prospectively with clinical and MRI assessments per clinical standard-of-care for a total of 12 months.
Aim 1
- 5 mCi FES +/- 10% will be injected intravenously (per manufacturer's recommendations). FES PET/CT will be obtained in dynamic 3D list mode for 90 minutes starting from injection.
- Kinetic analysis of dynamic PET images will be carried out using a reversible 1-tissue-2- compartment model as well as Logan Vt, and the influx rate constant, Ki, and distribution volume, Vt, will measured respectively.
- Static 10min PET images will be generated for from 50 to 80 min on a 10min increment, and the corresponding SUV's and tumor-to-background ratios will be compared to that in the 80- 90min imageset, a workflow that previously established by our group using DOTATATE PET/MR in meningioma, and using FLT/FMISO PET/CT in high-grade glioma.
- Tumor volume will be delineated using PMOD (PMOD, Zurich), a dedicated tool for PET analyses and kinetic modeling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Active diagnosis of ER+ breast cancer (biopsy proven) and new or recurrent brain metastases (biopsy proven or suspected based on MRI appearance)
- •Ability to provide informed consent
- •Discontinuation of ER modulators for at least 8 weeks, and discontinuation of ER down regulators for at least 28 weeks (as per manufacturer guidelines)
- •Age >=18 years
- •Eastern Cooperative Oncology Group performance score 0-1
- •Life expectancy >=6 months
- •Planned for radiation treatment for brain metastases
排除标准
- •Unable to undergo Standard of Care
- •Allergy to FES.
结局指标
主要结局
SUV Ratio
时间窗: 3 years
Standardized uptake value ratio of target lesion over reference region.
Target-to-Background Ratio
时间窗: 3 years
Qualitative appearance of lesion delineation on PET.
Distribution volume (Vt) for scan times
时间窗: 3 years
Distribution volume (Vt), measured within the same region of interest as that for Maximum SUV, for scan times ranging between 45 min and 85 min with 5min intervals and corresponding results will be compared to those measured with the full dataset at 90mm.
Influx (Ki)
时间窗: 3 years
Parametric PET analysis results within the same region of interest as that for Maximum SUV.
Mean SUV
时间窗: 3 years
Mean standardized uptake value within a region of interest placed based on MRI findings of suspicious brain lesion.
Maximum SUV
时间窗: 3 years
Maximum standardized uptake value within a region of interest placed based on MRI findings of suspicious brain lesion.
次要结局
- Proportion of cases in which there was a change in management based on FES PET/CT(3 years)